Endotracheal tube cleaning apparatus

ABSTRACT

An endotracheal tube cleaning apparatus to be used with an endotracheal tube, the cleaning apparatus having an elongate tubular member with a distal end that extends into the endotracheal tube and a channel defined therethrough and terminating at a distal end disposed in a vicinity of the distal end of the elongate tubular member. A cleaning assembly is provided at the distal end of the elongate tubular member so as to engage the interior wall structure of the endotracheal tube, as a result of a resilient material bladder, for cleaning thereof. A ventilator coupling is further provided and is connected to the endotracheal tube, a first inlet port of the ventilator coupling being coupled to a ventilator assembly to supply air to a patient, and a second inlet port of the ventilator coupling being structured to receive the elongate tubular member therethrough into the endotracheal tube. Also, a bypass coupling assembly is connected between the channel of the elongate tubular member and the ventilator assembly so as to automatically direct air from the ventilator assembly into the channel of the elongate tubular member, and out the distal end of the channel, upon occlusion of a flow of the air through the endotracheal tube at a point of the endotracheal tube upstream of the distal end of the channel.

CLAIM OF PRIORITY

The present application claims priority to and is a divisional patentapplication of pending application Ser. No. 09/608,026, filed Jun. 30,2000, which is a Continuation-In-Part application of previously filed,now application having Ser. No. 08/928,113 which was filed on Sep. 12,1997 now U.S. Pat. No. 6,082,361, which is a Continuation-In-Part ofUnited States patent application having Ser. No. 08/613,277 filed Mar.11, 1996, also incorporated herein by reference, which matured into U.S.Pat. No. 5,709,691 on Jan. 20, 1998.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an endotracheal tube cleaning apparatusto be used to effectively and efficiently clean the flow through passageof an endotracheal tube, including the effective removal of even solidbuildup on the interior wall surface of the endotracheal tube safely,effectively, and in a self contained sterile assembly that does not haveto be removed from the patient, does not significantly restrict airflowto the patient, and may be used to administer needed medication.Furthermore, the cleaning apparatus is structured to ensure that apatient is still capable of effective breathing, even during cleaning,and to enable effective examination and cleaning of the cleaningassembly during continued uses, thereby ensuring that excessive build upis not on the cleaning assembly during continued cleaning of theendotracheal tube.

2. Description of the Related Art

Many patients in a hospital, and in particular, patients in an IntensiveCare Unit (“ICU”) must be fitted with endotracheal tubes to facilitatetheir respiration. Specifically, an endotracheal tube is an elongate,semi-rigid lumen which is inserted into a patient's nose or throat andprojects down into airflow communication with the patient's respiratorysystem. As such, the patient either directly, or with the aid of arespiratory unit, is able to breathe more effectively through theendotracheal tube.

Recent studies have determined, however, that the accumulation of driedtracheobronchial secretions on the interior wall surface of an operatingendotracheal tube effectively decreases the lumen cross section, andthereby significantly increases the work of breathing for the intubatedpatient. Moreover, increasing the work of breathing for the patientnecessitates that a higher level of support be provided to compensate,and often results in the patient's intubation period and ICU stay beingsignificantly prolonged. Furthermore, it is also seen that thicksecretions on the walls of the endotracheal tube often serve as a nidusfor continued infection in the lungs, leading to added morbidity andhospital costs for the intubated patient.

To date, the only effective means of eliminating the accumulatedsecretions within an endotracheal tube completely, has been to exchangethe contaminated endotracheal tube for a new tube. There are, however,several disadvantages to this procedure, such as temporary arrest ofventilatory support and the risk of complete loss of airway control. Forexample, reintubation may be exceedingly difficult in patients withswelling of the soft tissue of the neck, and in patients having cervicalspine immobilization, because upon removal of the endotracheal tube, theappropriate internal passages tend to close up and be otherwisedifficult to isolate for reintroduction of a new endotracheal tube.Further, reintubation of a patient can result in additional trauma tothe oral, laryngeal and tracheal tissues.

Short of replacing the endotracheal tube completely, the only othermeans currently in use for maintaining endotracheal tubes somewhat clearis the use of flexible suction/irrigation catheters. Specifically, thesesuction/irrigation catheters, are passed down the endotracheal tube andupper airways and seek to evacuate contaminants from the lumen.Unfortunately, although the suction/irrigation catheters generally clearthe airway of watery secretions, they are ineffective at clearing theinspissated secretions that have accumulated on the inner wall surfaceof the endotracheal tube over the course of days.

In essence, the use of a suction/irrigation catheter merely delays theinevitable, namely, that the endotracheal tube be removed and replaced.

One somewhat recent attempt to address the problems associated with themaintenance of endotracheal tubes is seen to provide a two part assemblywhich is introduced into the flow through passage of the endotrachealtube. Specifically, a thin interior, solid segment having a plurality ofretracting bristles and a sealing gasket at an end thereof is containedwithin an exterior lumen. In use, the entire coupled assembly isintroduced into the endotracheal tube, but the interior segment ispushed through the outer tube so that the bristles expand to engage thewall surface, and the gasket member, such as a foam cylinder or balloon,expands to completely seal off the area behind the bristles. The entiredevice, including the upwardly angled bristles is then pulled upwardlywith the gasket element completely sealing off the tube there below sothat any debris removed by the bristles is retained. Such a device,however, does not provide for accurate insertion indication to preventover-insertion into the endotracheal tube, and completely seals off theendotracheal tube during removal so as to result in a potentiallyhazardous interruption to ventilation and/or a negative pressure orsuction behind the cleansing device. Furthermore, it is seen from theneed to include the bristles, that direct engagement of a gasket typemember, such as the balloon, with the interior wall surface of theendotracheal tube, does not provide for the complete and effectiveremoval of secretions, due primarily to the smooth exterior surface ofthe gasket. Moreover, the smooth resilient material surface also resultsin substantial friction between the rubbery gasket and the plastic wallsurface, thereby making it quite difficult to smoothly and effectivelypull the cleansing device from the endotracheal tube. Additionally, itis seen that upwardly angled bristle members are susceptible to completeor partial retraction as they encounter obstacles and attempt to scrapeclean the interior of the endotracheal tube, and in fact, the bristlemembers are often quite sharp and may be damaging to the endotrachealtube or to a patient if inadvertently projected beyond the endotrachealtube so that the outwardly projecting bristle members become stuckoutside the endotracheal tube. Also, because of the collapsingconfiguration of bristles, gaps will naturally exist between adjacentbristles and some areas of the tube are not engaged, and as secretionsbegin to build up beneath the bristles, their collapse is furtherrestricted. Further, such a single function device necessitates thatadditional items be introduced into the tube, generally resulting inadditional trauma to the patient, if some suction is necessary.

As such, there is still a substantial need in the art for a cleaningdevice that can be used to clear endotracheal tube secretionseffectively, and on a regular basis, thereby expediting ventilatoryweaning and extubation of ICU patients. Further, there is a need for aneffective endotracheal tube cleaning apparatus which can be easily andeffectively introduced into the endotracheal tube, and which can beeasily removed, even though it effectively removes solid secretionbuildup, due to its friction minimizing engagement with the interiorwall surface of the endotracheal tube and/or because of its alleviationof negative pressure/suction within the endotracheal tube upon removalthereof. Additionally, there is a need for a cleaning device which canbe accurately extended into the endotracheal tube without substantialrisk of over introduction, will not become lodged through theendotracheal tube in the event that it protrudes slightly from the endof the endotracheal tube, and which can be utilized for multiplefunctions, such as the introduction of medication deep into thepatient's airway.

In addition to the referenced needs in the industry, it is also notedthat an effective cleaning device should preferably be configured tomaintain air flow/ventilation to a patient during substantially allphases of cleaning. Moreover, the device should maintain maximum sterileintegrity as to those components which will be ultimately introducedinto the patient, providing for effective cleaning and/or monitoringthereof.

SUMMARY OF THE INVENTION

The present invention is directed towards an endotracheal tube cleaningapparatus to be used to clean an endotracheal tube while it is beingused in an intubated patient. Typically, the endotracheal tube is of thetype that includes a central lumen, defined by an interior wallstructure that extends from a distal end to a proximal end of the tube.

Specifically, the endotracheal tube cleaning apparatus includes anelongate tubular member having a diameter smaller than the interiordiameter of the endotracheal tube. Further, the elongate tubular memberincludes a distal end that is structured to be introduced and extendinto the lumen of the endotracheal tube. Defined within the elongatetubular member, and extending from generally its first/proximal end toits second/distal end is a channel. The channel provides a fluid flowthrough conduit that terminates in an outlet port defined in theelongate tubular member, generally near the second end thereof.

Also disposed in a vicinity of the distal end of the elongate tubularmember is a cleaning assembly. The cleaning assembly, which may be atleast partially removably secured to the elongate tubular member,includes an inflatable resilient material bladder having an exteriorcleaning surface, such as an exterior abrasive surface. The exteriorcleaning surface is structured to affirmatively engage the interior wallstructure of the endotracheal tube with some outward cleaning pressure,for subsequent cleaning of the endotracheal tube upon reciprocatingmovement of the elongate tubular member within the endotracheal tube.

Additionally, the endotracheal tube cleaning apparatus may, in oneembodiment, include a ventilator coupling. The ventilator coupling isstructured to be coupled in fluid flow communication with theendotracheal tube, and includes a first inlet port and a second inletport defined therein. Specifically, the first inlet port is structuredto be coupled to a ventilator assembly and thereby provide air to thepatient in a conventional manner through the endotracheal tube. Thesecond inlet port, however, is structured to receive the elongatetubular member therethrough for subsequent passage into the endotrachealtube, and as such is preferably disposed in axial alignment with theendotracheal tube.

In order to ensure that the patient is consistently ventilated, a bypasscoupling assembly may also be provided. The bypass coupling assembly isdisposed/connected in fluid flow communication between the channel ofthe elongate tubular member and the ventilator assembly. Moreover, it isstructured and disposed to automatically direct the fluid from theventilator assembly, into the channel of the elongate tubular member,and out the distal end of the channel, upon occlusion of a flow of airthrough the endotracheal tube at a point of the endotracheal tubeupstream of the distal end of the channel. Accordingly, if normalventilation stops, ventilation through the bypass coupling assembly willcontinue.

It is an object of the present invention to provide an endotracheal tubecleaning apparatus which can efficiently and easily be routinelyutilized to maintain the flow through passage of an endotracheal tubefree from the accumulation of dried tracheobronchial secretions.

A further object of the present invention is to provide an endotrachealtube cleaning apparatus which can easily and effectively be oriented soas to prevent over insertion into endotracheal tubes of varying lengths.

Yet another object of the present invention is to provide anendotracheal tube cleaning apparatus which can absorb watery secretionsas well as remove dried secretions from the interior wall surface of anendotracheal tube.

Also an object of the present invention is to provide an endotrachealtube cleaning apparatus which provides sufficient abrasion to removedried secretions from the interior wall surface, but which is alsosubstantially smooth and easy to slidingly remove from the endotrachealtube while it is engaged with the interior wall surface thereof.

Another object of the present invention is to provide an endotrachealtube cleaning apparatus which can provide effective cleaning pressure onthe interior wall surface of the endotracheal tube, but which providesminimal risk of external contamination through the rupture of aresilient material bladder thereof.

A further object of the present invention is to provide an endotrachealtube cleaning apparatus which can alleviate negative pressure deepwithin the endotracheal tube while the cleaning device is engaging thewall surface of the endotracheal tube during cleaning.

Still another object of the present invention is to provide anendotracheal tube cleaning apparatus which can simultaneously provideabrasive dried secretion removal with effective suction/irrigation toremove watery secretions.

Yet another object of the present invention is to provide anendotracheal tube cleaning apparatus which can be utilized to perform avariety of functions during a single insertion.

Another object of the present invention is to provide an endotrachealtube cleaning apparatus which can be utilized to suction a patient'sairway and will not harm the patient if inserted beyond the tube forthat purpose.

Also an object of the present invention is to provide an endotrachealtube cleaning apparatus which automatically functions to ensure that apatient is ventilated, even if normal air flow through the endotrachealtube is occluded during cleaning.

A further object of the present invention is to provide an endotrachealtube cleaning apparatus which can provide for effective, isolatedirrigation of the cleaning assembly, thereby permitting safere-introduction and added cleaning of the endotracheal tube therewith.

Also an object of the present invention is to provide an endotrachealtube cleaning apparatus which can assist with the introduction ofmedication at an effective deployment site within the patient's airway.

Another object of the present invention is to provide an endotrachealtube cleaning apparatus which is convenient to grasp and manipulate andwhich provides for easy adjustment of the inflated amount of theresilient material bladder.

An added advantage of the present invention is to provide anendotracheal tube cleaning apparatus which is substantially sterile andcontained both during introduction and during removal and internalirrigation.

A further object of the present invention is to provide a cap assemblywhich remains in a substantially protected state both when in use andnot in use.

These and other features and objects, each of which may or may not bepresent in every embodiment of the present invention will become moreclear when the drawings as well as the detailed description are takeninto consideration.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature of the present invention,reference should be had to the following detailed description taken inconnection with the accompanying drawings in which:

FIG. 1 is a side view of the endotracheal tube cleaning apparatus of thepresent invention in an operative orientation within an endotrachealtube;

FIG. 2 is an isolated, side cross-sectional view of the elongate tubularmember and handle assembly of the endotracheal tube cleaning apparatusof the present invention;

FIG. 3 is an isolated side view of the resilient material bladder andexterior sheath in an operative, cleaning position within anendotracheal tube;

FIG. 3A is an isolated side view of another embodiment of the resilientmaterial bladder in an operative, cleaning position within anendotracheal tube;

FIG. 4 is an isolated view of the elongate tubular member of theendotracheal tube cleaning apparatus of the present inventionillustrating the orientation of the resilient material bladder andexpandable exterior sheath when not in an operable, cleaningorientation;

FIG. 5 is an isolated view of the preferred embodiment of theendotracheal tube cleaning apparatus of the present invention;

FIG. 6 is an exploded view of the preferred embodiment of theendotracheal tube cleaning apparatus of the present invention; and

FIG. 7 is an isolated, enlarged, cross section view of area A of FIG. 6.

Like reference numerals refer to like parts throughout the several viewsof the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Shown throughout the Figures, the present invention is directed towardan endotracheal tube cleaning apparatus, generally indicated as 10. Inparticular, the endotracheal tube cleaning apparatus 10 is constructedfor use with an endotracheal tube 80 that is conventionally utilized toenable a patient to breathe, and as such, is generally inserted down thethroat of a patient as illustrated in FIG. 1. Such an endotracheal tube80 is preferably of the type including a flow through passage 82 havingan interior wall surface 83 that defines its interior diameter.Generally, however, after prolonged periods of use, the endotrachealtube 80 will exhibit a buildup of secretions 85 that form on theinterior wall surface 83 and can thereby obstruct airflow through theflow through passage 82. The endotracheal tube cleaning apparatus 10 ofthe present invention, among other functions, is structured tofacilitate the removal of those secretions 85 in a convenient andeffective manner.

In particular, the endotracheal tube cleaning apparatus 10 of thepresent includes an elongate tubular member 20 having a first/proximalend 24 and a second/distal end 22. The elongate tubular member 20, whichis preferably of a semirigid construction so as to allow it to bend andconform to the operative configuration of the endotracheal tube 80within a patient, has a length at least equivalent to a length of theendotracheal tube 80. As such, the endotracheal tube cleaning apparatus10 can effectively reach deep down into the length of the endotrachealtube 80 for effective cleaning of even the most remotely introducedportions thereof. Furthermore, the elongate tubular member 20 isstructured with a diameter smaller than the interior diameter of theendotracheal tube 80, and in fact, is preferably quite narrow so as tofacilitate the introduction of the elongate tubular member 20 intoendotracheal tubes of varying sizes and permit normal airflow thereaboutin most circumstances. Preferably disposed on an exterior surface of theelongate tubular member 20 is a gradiated indicia 62. In particular, itis generally not favorable for the second end 22 of the elongate tubularmember 20 to penetrate beyond an open end of the endotracheal tube 80,as it may come in contact with interior organs and/or tissue of thepatient. As such, upon knowing the dimensions of the endotracheal tube80 being utilized within the patient, a user can make note of anappropriate marking on the indicia 62, which may include lines orpreferably numerals, to ensure that the elongate tubular member 20 isnot over inserted into the endotracheal tube 80.

Preferably defined within the elongate tubular member 20 is an inflationchannel 30. Specifically, the inflation channel 30 is structured toextend from generally the first end 24 of the elongate tubular member 20towards the second end 22 of the elongate tubular member 20. Moreover,the inflation channel 30 will preferably terminate in an outlet port 32defined generally near the second end 22 of the elongate tubular member20. The outlet port 32 of the inflation channel 30 is structured anddisposed so as to permit the escape of a fluid, such as air,therethrough, subsequent to its passage through the length of elongatetubular member 20 within the inflation channel 30. As illustrated in thepreferred embodiment of the drawings, the outlet port 32 of theinflation channel 30 preferably extends out a side of the elongatetubular member 20, in a vicinity of the second end 22 of the elongatetubular member 20, and may preferably extend into an annular trackdefined in the elongate tubular member 20.

Secured to the elongate tubular member 20, also generally at the secondend 22 thereof as part of a cleaning assembly 40′ is a resilientmaterial bladder 40. Preferably the resilient material bladder 40engages the elongate tubular member 20 within the annular track, and assuch is disposed over the outlet port 32 of the inflation channel 30.Accordingly, the resilient material bladder 40 is structured anddisposed to be in fluid flow communication with the outlet port 32 andhence the inflation channel 30. Therefore, when a fluid, such as air,exits the inflation channel 30 through the outlet port 32, it will passinto the resilient material bladder 40 to result in a correspondinginflation thereof. Specifically, the resilient material bladder 40 isformed of an expandable material and is preferably structured to inflateto at least a diameter that is approximately equivalent to a diameter ofthe interior wall surface 83 of the endotracheal tube 80, therebyexerting some outward pressure on the endotracheal tube 80 when it isinflated. Additionally, the resilient material bladder 40 may be sizedto be variably inflated and thereby permit effective use of theendotracheal tube cleaning apparatus 10 within endotracheal tubes 80having varying interior diameters. The resilient material bladder 40 maybe secured to the elongate tubular member 20 in a variety of fashions,and may take on a variety of configurations effective to provide forappropriate inflation and secure retention at generally the second end22 of the elongate tubular member 20. By way of example, the resilientmaterial bladder 40 can have an inner-tube type configuration secured tothe elongate tubular member 20 and having inlet opening connected influid flow communication with the outlet port 32 of the inflationchannel 30. Alternatively, the resilient material bladder 40 can have atire-type configuration wherein the resilient material 40 has agenerally C-shaped cross section and forms a seal between its edges andthe exterior surface of the elongate tubular member 20 in order tocaptivate air therebetween for the resultant inflation of the resilientmaterial bladder 40. Along these lines, the resilient material bladdermay be structured to be removable from the elongate tubular member 20,such as after a single use. In such an embodiment, rather than securingthe edges of the resilient material bladder to the elongate tubularmember, such as using an adhesive, the resilient material bladder 40 isremovably seated within the annular track 33. Accordingly, the generallyresilient nature of the resilient material bladder 40 preferablymaintains it secured in place, however, when necessary, it may be pulledout of the track and slid off of the elongate tubular member.Furthermore, if desired it is noted that the entire distal end of theelongate tubular member may be structured to be removable as a unit,thereby providing for the disposability of the resilient materialbladder 40 as well.

Disposed at least partially, but preferably completely about theresilient material bladder 40, in at least one embodiment is anexpandable, exterior sheath 42. In the this embodiment, the expandableexterior sheath 42 is specifically structured and disposed to completelycontain the resilient material bladder 40, and thereby prevent passageof any portion of the resilient material bladder 40 down into theendotracheal tube 80 should the resilient material bladder 40 ruptureduring inflated use. Furthermore, the expandable, exterior sheathincludes an exterior, generally abrasive surface, preferably along anentire exterior surface of the exterior sheath, which will engage, witha degree of outward cleaning pressure as translated from the resilientmaterial bladder to which it conforms, and will thereby clean the entireinterior wall surface 83 of the endotracheal tube 80 when the resilientmaterial panel 40 is inflated. Preferably, the expandable exteriorsheath 40 has a soft, expandable, mesh type configuration which canengage an entire circumference of the interior wall surface 83 with agenerally large surface area. Conversely, when the resilient materialbladder 40 is collapsed, as illustrated in FIG. 4, the expandableexterior sheath 42 is also collapsed, but does not sag or droop. Rather,the gaps within the mesh type configuration of the expandable exteriorsheath 42 will merely reduce and the mesh will normally maintain itsmore tightly packed mesh configuration. Alternatively, however, when theresilient material bladder 40 is inflated, the expandable mesh typeconfiguration of the expandable exterior sheath 42 permits it to stretchout and maintain its covering relation over the resilient materialbladder 40. It is therefore seen, that the plurality of openings definedin the expandable exterior sheath 42, when it is expanded and wrappedabout an inflated, operable resilient material bladder 40, provide agenerally abrasive exterior surface that when passed over the interiorwall surface 83 of the endotracheal tube 80 with some outward cleaningpressure, will function to loosen the secretions 85 that are stuck tothe interior wall surface 83 of the endotracheal tube 80. Accordingly,effective cleaning results when the resilient material bladder 40 isinflated and the elongate tubular member 20 is pulled out from itsinserted orientation within the flow through passage 82 of theendotracheal tube. It is also seen, however, that some in and out,reciprocating movement of the elongate tubular member 20 may benecessary to provide for complete and effective secretion 85 removal.Moreover, in the preferred embodiment, a small distance, namely a safetydistance, is preferably maintained between the resilient materialbladder 40 and the tip of the elongate tubular member 20 at the secondend 22. Accordingly, a risk of over introduction of the cleaningassembly 40′ beyond the endotracheal tube 80 is minimized when anintroduction distance is equated to a length of the elongate tubularmember 20, as will be described.

In addition to containing the resilient material bladder 40 in case ofrupture, and providing the exterior, generally abrasive surfacenecessary for cleaning, the expandable exterior sheath 42, which may beformed of a nylon or other soft material mesh, also provides a smoothexterior surface that facilitates movement during introduction andremoval of the resilient material bladder 40, and therefore theelongatetubular member 20, into and out of the endotracheal tube 80during cleaning. Specifically, because of the material construction ofthe resilient material bladder 40, significant friction may be exhibitedbetween the resilient bladder 40 itself, and the interior wall surface83 of the endotracheal tube 80. Such frictional resistance may make itquite difficult, or at least quite erratic during the removal and/orreintroduction of the resilient material bladder 40 into theendotracheal tube 80. Furthermore, the expandable exterior sheath canmore effectively absorb and/or remove the secretions if the resilientmaterial bladder 40 can be retained in an inflated orientation as theendotracheal tube cleaning apparatus 10 is completely removed from theendotracheal tube 80, because any dislodged secretions 85 aresubstantially prevented from dropping beneath the resilient materialbladder 40 where they may fall into the patient. Furthermore, ifdesired, a quantity of medication can be administered, such as throughapplication on the exterior sheath 42. In particular, the medication canbe administered either to the patient directly by passing the distal endof elongate tubular member completely through the endotracheal tube, ormay be administered to the surface of the endotracheal tube, such as inthe case of an anti-bacterial agent, mucolytic agent, saline solution,etc., to help clean and disinfect the endotracheal tube, to preventfuture contamination, and/or for gradual distribution to the patient viathe endotracheal tube.

Looking to FIG. 3A, in yet another embodiment of the present inventionthe exterior abrasive surface of the cleaning assembly 40′ may bedefined by a ribbed exterior surface 47 of the resilient materialbladder 40. In such an embodiment a plurality of ribs are defined in theresilient material bladder those ribs providing a sufficient abrasivesurface, when the resilient material bladder is inflated, to gentlyclean the endotracheal tube. Furthermore, medication or a lubricatingmaterial may be placed on the ribs so as to facilitate movement withinthe endotracheal tube, and/or as may be necessary for the patient. Assuch, in this embodiment, although the exterior sheath may still beprovided, it is not necessary.

Disposed opposite the outlet port 32 of the inflation channel 30, andalso connected in fluid flow communication with the inflation channel 30is an inlet port 34. Specifically, the inlet port 34 is structured topermit the introduction of a fluid, preferably air, into the inflationchannel 30 for subsequent inflation of the resilient material bladder40. While this inlet port 34 may be positioned anywhere in the elongatetubular member 20, it is preferred that it be positioned generally nearthe first end 24 thereof in order to permit the facilitated introductionof fluid therethrough when the elongate tubular member 20 issubstantially introduced into the endotracheal tube 80. Moreover, in apreferred embodiment the inlet port 34 is operatively disposed at aslight angle from an axis of the elongate tubular member 20 to permitfacilitated introduction of air into the channel 30.

Looking to the preferred embodiment of the figures, coupled to theelongate tubular member 20, preferably at its first end is a handleassembly 190. Specifically, the handle assembly 190 is preferablydisposed in a generally perpendicular orientation relative to theelongate tubular member 20, and may include a generally T-shapedconfiguration. As such, it is seen that a user may grasp the handleassembly 190 with the elongate tubular member 20 extending out frombetween the user's fingers, and reciprocating movement of the elongatetubular member 20 within the endotracheal tube 80 is greatlyfacilitated.

Preferably included within the handle assembly 190 is an inflationassembly. In particular, the inflation assembly is structured tofacilitate the introduction of the fluid into the inflation channel 30of the elongate tubular member 20 through the inlet port 34. In thepreferred embodiment, the inflation assembly includes a chamber 192defined therein and disposed in fluid flow communication via a conduit194 with the inlet port 34. As such, it is seen that the handle assembly190 preferably encases the first end 24 of the elongate tubular member20 such that the interconnection with the inlet port 34 is internallycontained. Of course a number of coupled interconnections can beachieved between the conduit 194 and the inlet port 34 and chamber 192,such as threaded, snap-fit, friction, or molded connections. Moreover,the conduit 194 may include a separate flexible element or may be moldeddirectly into the body of the handle assembly 190. Looking to thechamber 192, although a variety of separate and/or integrally moldedinflation mechanisms may be provided for connection at the chamber 192,it is preferably structured to receive a hypodermic syringe 193 therein.The syringe 193, which typically includes a threaded hub tip, isstructured to screw into, or be otherwise coupled within the chamber 192so as to direct air or liquid exiting the syringe 193 into the conduit194. Accordingly, with the perpendicular configuration of the handleassembly 190, it is seen that a user grasping the handle assembly 190may also easily place his/her thumb in actuating relation on the syringe193. Therefore, a user can actually control the amount of fluid withinthe inflatable bladder 40, and the outward pressure being exertedthereby on the endotracheal tube 80, while reciprocating movement of theelongate tubular member 20 is performed. Also, although separate valvemeans may be provided to restrict the escape of fluid after theresilient material bladder has been filled, in circumstances were thesyringe 193 is coupled to the handle assembly 190 and therefore thechannel 30 at the inlet port 34, it functions to prevent the escape ofair and the deflation of the resilient material bladder 40 whilepressure is maintained thereon by the user.

Also in the preferred embodiment, the endotracheal tube cleaningapparatus 10 of the present invention includes an equilibrium channel50. Specifically, the equilibrium channel 50 includes a distal end and aproximal end and is defined in the elongate tubular member 20 so as toextend from generally the first end 24 of the elongate tubular member 20to generally the second end 22 of the elongate tubular member 20, at apoint beyond the resilient material bladder 40. Moreover, theequilibrium channel 50 includes ports 52 and 54 at generally the firstand second ends of the elongate tubular member 20. Accordingly, theequilibrium channel 50 will provide a passage that significantlyalleviates suction/negative pressure behind the resilient materialbladder 40 as it is being removed from the endotracheal tube 80 in itsinflated orientation. It is understood, that when the resilient materialbladder 40 is inflated it effectively forms a seal with the interiorwall surface 83 of the endotracheal tube 80. Therefore, as the elongatetubular member 20 is pulled for cleaning, a suction effect behind theresilient material 40 can result. Not only can this suction effect makeit substantially more difficult to remove the endotracheal tube cleaningapparatus 10 from the endotracheal tube 80, but some trauma can resultto the patient as a result of this suction effect and a loss ofcontinued ventilation through the endotracheal 80 can result. Throughthe positioning of the equilibrium channel 50, the suction pressure isalleviated, and in fact, some air flow may be provided to the patienttherethrough. Moreover, as will be described subsequently, theequilibrium channel 50 can be used as a conduit for various otherfunctions of the present invention.

While the elongate tubular member 20 may be structured so as to beextended directly through a conventional Y-connector of the ventilatorassembly 170 implemented in a normal fashion at an exposed end of theendotracheal tube 80, thereby permitting the continuance of air flowthrough one inlet of the Y-connector, while permitting introduction ofthe elongate tubular member 20 through the other inlet of theY-connector, in the preferred embodiment, a ventilator coupling 160 isprovided. Specifically, the ventilator coupling 160 includes at leasttwo, but preferably three inlet ports 162, 163 & 165, and an outlet port164. The outlet port 164 is structured to be coupled, preferablydirectly with the endotracheal tube 80, in a standard manner so as toallow complete access to the endotracheal tube 80 therethrough.Similarly, the first inlet port 165 is structured to be coupled directlyto the ventilator assembly 170 at a connector hub 171 thereof. A typicalpress fit engagement may also be provided. Along these lines, however,and because ventilators having varying sized connector hubs 171 may beprovided, the preferred third inlet port 163 is also provided andconfigured of an alternative diameter to be coupled to a ventilatorassembly. For example, one inlet port may be 22 mm and another 15 mm. Ofcourse, when a particular inlet port 163 or 165 is not in use forconnection with the ventilator assembly 170, it may be used to provideaccess for other purposes and to other implements, or it may be merelysealed of by a corresponding cap 166 or 167. Looking to the second inletport 162, it is structured to receive the elongate tubular member 20therethrough, and is therefor preferably disposed directly in axialalignment with the entrance of the endotracheal tube 80.

In the preferred embodiment, the second inlet port 162 is coupled with ahub assembly 120 at an open second end 128 thereof. Specifically, thehub assembly 120 is structured to receive and preferably guide theelongate tubular member 20 therethrough and into the endotracheal tube80 through the ventilator coupling 160. Moreover, when retracted, thesecond end 22 of the elongate tubular member 20 is preferably disposedin the hub assembly 120 to provide some sanitary containment.

Extending from a first end 127 of the hub assembly 120. is a collapsibleexterior sheath 110. Specifically, the exterior sheath 110 is formed ofa flexible, preferably transparent material, and is secured at oppositeends thereof between the handle assembly 190 and the hub assembly 120. Atypical collar coupling 112 and 114 is preferred so as to preventseparation. As such, a length of the exterior sheath 110 functions torestrict outward removal of the elongate tubular member 20 completelyout of the hub assembly 120. Moreover, the elongate tubular member 20 ismaintained in a completely isolated, completely sterile environment topreventits contamination and to prevent it from contaminating otheritems.

Furthermore, it is preferred that the hub assembly 120 include a sealassembly 125 disposed at the first end 127 thereof. The seal assembly125 preferably includes a resilient gasket type configuration and isstructured to maintain the elongate tubular member 20 generallyconcentrically disposed through the hub assembly 120. Further, the sealassembly 125 is structured to engage the elongate tubular member 20 asit is withdrawn therethrough so as to substantially wipe off anyaccumulated secretions from its exterior surface and preferably providea generally fluid impervious seal with the elongate tubular member 20 atthe first end 127 of the hub assembly 120.

In addition to providing an effective connection point with theventilator coupling 160, the hub assembly 120 is further structured anddisposed to facilitate cleaning and irrigation of the second end 22 ofthe elongate tubular member 20 and the cleaning assembly 40′, and canallow for testing of the cleaning assembly 40′. For example, the hubassembly 120 is preferably somewhat narrow at the first end 127,approximating a diameter of the endotracheal tube 80, and therebyhelping to guide the elongate tubular member 20 along a concentric pathand permitting a user to get a feel for the cleaning process whileactually viewing the cleaning assembly 40′ if a slight, cleaning typeinflation of the resilient material bladder 40 is desired. Conversely,the hub assembly is generally wider at the second end 128 so as topermit full inflation of the resilient material bladder 40 if a test ofits integrity or the loosening of built up secretion is necessary. Inparticular, the hub assembly 120 further includes a port 122 connectedtherewith. This port 122 may act as an irrigation port when cleaning ofthe second end 22 of the elongate tubular member 120 is desired. Forexample, as the elongate tubular member 20 is withdrawn from theendotracheal tube 80 after cleaning, the seal assembly 125 maintains allexterior excretions within the hub assembly. When the second end 22 ofthe elongate tubular member 20 is completely within the hub assembly120, the hub assembly 120 is preferably removed from the ventilatorcoupling 160, and its second end 128 is preferably covered by a firstcap section 130 of a sterile cap assembly, to be described in greaterdetail subsequently. Furthermore, the hub assembly 120 is preferablyformed of a generally transparent material so as to permit viewing ofthe area to be cleaned. Once the hub assembly 120 is sealed, anirrigation fluid, preferably under some pressure is directed through theport 122 to wash off the second end 22 of the endotracheal tube 20, andtherefore the cleaning assembly 40′. That irrigation fluid may then bedrained or suctioned out.

Specifically, the port 122 is preferably coupled with a multi-port valve144. As such, one auxiliary port 144′ of the multi-port valve 144 may beconnected via an appropriate suction coupling 148 to a suction hose 150,while another opening of the multi-port valve 144 is coupled in fluidflow communication with an irrigation fluid source, such as a syringe.Looking to the suction coupling 148, it may be covered with acorresponding cap 149 when not in use, however it will preferably beconnected to a typical suction pump via a suction hose 150, a specimentrap 152 to filter out any suctioned particulate and collect them foranalysis, and a secondary hose 154 connected to a suction source.

Furthermore, the suction means may also be coupled in fluid flowcommunication with the equilibrium channel 50. Specifically, the suctionmeans when coupled with the equilibrium channel are structured anddisposed to withdraw residue cleaned from the interior wall surface 83of the endotracheal tube 80, and not captivated at or above theresilient material bladder 40 during cleansing. Moreover, the suctionmeans can draw out watery secretions, which are generally more difficultto completely eliminate through the resilient material bladder 40 andexpandable exterior sheath 42, through the equilibrium channel 50.Similarly, the suction means can function to suction a patients airway,beyond the endotracheal tube, in some circumstances, by introducing thesecond end 22 of the tubular member 20 beyond the endotracheal tube 80.With regard to the suction function, it is understood that the distalend port 52 of the equilibrium channel 50 may be disposed right at a tipof the second end 22 of the elongate tubular member 20, may be disposedin a side wall of the elongate tubular member 20, and/or may in factinclude more than one port 52 so as to provide for more effectivesuction within the endotracheal tube 80. Further, it is also understoodthat the equilibrium channel 50 may be divided into a pair of channels,one to provide for suction and another to provide for alleviation ofremoval resisting suction pressure behind the resilient material bladder40 during inflated removal.

Looking more particularly the preferred embodiment of the figures, theport 52 is preferably connected to an elongate, preferably flexibleconduit 140 disposed at an intake port 195 of said handle assembly 190.Specifically, the intake port 195 of the handle assembly 190 ispreferably connected in fluid flow communication with a port 54 of theequilibrium channel 50 disposed at the first end 24 of the elongatetubular member 20. This interconnection is preferably internal of thehandle assembly 190 and may be accomplished by a molded interior channelor segment of flexible tubing 196. Of course, the intake port 195 of thehandle assembly 190 may merely include an opening through which theconduit 140 extends for direct coupling with the port 54 of theequilibrium channel 50 or the interior channel 196. Moreover, theequilibrium channel 50 may extend to the intake port 195. In thepreferred embodiment, however, a second multi-port valve 146 is coupledto the intake port 195, and the conduit 140 is coupled at opposite ends141 and 142 thereof to the corresponding multi-port valves 144 and 146.In this configuration, it is seen that when the first multi-port valve144 is positioned to direct flow between the suction coupling 148 andthe conduit 140, and the second multi-port valve 146 is positioned topermit flow from the conduit 140 to the intake port 195, the suction isdirected through the equilibrium channel 50 to achieve the airwaysuctioning function previously described. Moreover, use of theseconventional multi-port valves 144 or 146 allows facilitated control ofthe application of suction merely by blocking or permitting flow.Conversely, during irrigation within the hub assembly 120, the firstmulti-port valve 144 may positioned to direct flow between the conduit140 and the port 122, acting as the irrigation port, such that a syringeor other irrigation fluid source can be coupled with the conduit 140,such as at an auxiliary port 146′ of the second multi-port valve 146positioned to direct an irrigation fluid into the conduit 140, and candirect the fluid into the hub assembly 120. Subsequent to irrigation,the first multi-port valve 144 can be positioned to permit flow betweenthe suction coupling 148 and the port 122 on the hub assembly 120 tosuction out the irrigation fluid and any loosened debris. Alternatively,the irrigation fluid may be directed from a syringe through the secondmulti-port valve 146 directly into the equilibrium channel 50 forcleaning thereof. As such, irrigation fluid directed through either areawill accumulate in the hub assembly 120 where the cleaning assembly 40′,which must also be cleaned, is disposed.

The preferred embodiment of the present invention also includes a bypasscoupling assembly. Specifically, the bypass coupling assembly isconnected in fluid flow communication with the equilibrium channel 50 ofthe elongate tubular member 20, and the ventilator assembly 170.Moreover, the bypass coupling assembly is structured to automaticallydirect the air from the ventilator assembly 170 into the channel 50 ofthe elongate tubular member 20 and out the distal end of the channel 50at the second end 52 of the elongate tubular member 20, upon occlusionof a flow of air through the endotracheal tube at a point of theendotracheal tube upstream of the distal end of the channel 50.Generally, this occlusion of air flow is a result of inflation of theresilient material bladder 40, and as such the distal end of the channel50 located in a vicinity of the second end 22 of the elongate tubularmember 20 is downstream of that point and is still in fluid flowcommunication with the patient. In the preferred embodiment, the bypasscoupling assembly includes a bypass port disposed in fluid flowcommunication with a ventilator inlet port 165 of the ventilatorcoupling 160. As such, in the preferred embodiment, the port 122 of thehub assembly 120 acts as the bypass port. Moreover, the bypass couplingassembly includes the conduit 140 disposed in fluid flow communicationbetween the bypass port 122 and the channel 50 of the elongate tubularmember 20. Accordingly, if flow through the endotracheal tube 80 isconstricted, the air flow backs up into the hub assembly 120 where itescapes through the bypass port 122. With proper positioning of thefirst and second multi-port valves 144 and 146, that ventilating airflows into the channel 50 and out to the patient. Along these lines itis noted, that the endotracheal tube cleaning apparatus 10 of thepresent invention may be easily adapted, merely by selectivelyactuating/positioning the first and the second multi-port valves 144 and146, so as to selectively administer suction inside the endotrachealtube 80 through the channel 50, administer suction within the hubassembly 120 in order to withdraw secretions and irrigation fluidtherefrom, administer medication in liquid form to the patient throughthe channel 50 at a point beyond the endotracheal tube 80 and wellwithin the patient's airway, irrigate the cleaning assembly 40′ withinthe hub assembly 120, irrigate the channel 50, preferably into the hubassembly 120, and ventilate the patient through the channel 50 byimplementation of the bypass coupling. Accordingly, time consuming andpotentially complex disconnection of the conduit 140 from its fluid flowcommunication between the bypass port 122 and the channel 50 of theelongate tubular member 20 can be eliminated, while still effectivelyperforming a wide variety of functions.

In addition to the previously described preferred configuration of theendotracheal tube cleaning apparatus 10 of the present invention, theelongate tubular member 20 may include yet another elongate passageextending therethrough and having an outlet opening disposed generallyat a point above the resilient material bladder 40. As such, duringcleaning a suction can be applied above the resilient material bladder40 to remove any loosened debris and/or fluid that may affect or hinderthe cleaning process of the resilient material bladder 40. In thisembodiment, the equilibrium channel 50 may be used to maintainrespiratory air flow to the patient during cleaning as part of thebypass coupling assembly.

Yet another feature of the present invention, and preferablyincorporated at the second multi-port valve 146, are medicationadministration means. Specifically, a standard MDI adaptor 180 typefixture can be coupled to the second multi-port valve 146 when it ispositioned to direct flow between the adaptor 180 and the channel 50through the intake port 195 of the handle assembly 190. As such,preferably upon removal of a protective cap 183, a medication vial 185can be applied at the adaptor 180 and medication is administered intothe channel 50. While the medication may flow directly down and out thedistal end of the channel 50, generally the medication, especiallyliquid medication, will remain in the handle assembly 190 or upperregion of the equilibrium channel 50 until the second multi-port valve146 is positioned to block off the adaptor 180 and thereby open theconduit 140 permitting the bypass coupling assembly to be operational.At that point, the flow of air through the bypass coupling assemblyfunctions to push the medication out the port 52 of the channel 50disposed at the second end 22 of the elongate tubular member 20. As thiscan be accomplished when the elongate tubular member 20 is substantiallyintroduced into the endotracheal tube 80, and therefore the patient,substantially direct and focused administration of the medication in theairway is ultimately achieved.

Referring once again to the sterile cap assembly of the presentinvention, it is seen to include a first cap section 130 and a secondcap section 168. Specifically, the first cap section 130 of the sterilecap assembly is preferably structured to seal the second end 128 of thehub assembly 120 and thereby prevent an irrigating fluid from passinginto the ventilator coupling 160 and subsequently into the endotrachealtube 80, as previously described. In particular, the first cap section130 includes a sterile engagement face 132 that is matingly coupled withthe second end 128 of the hub assembly 120. Moreover, it is preferredthat the sterile engagement face 132 of the first cap section 130 be amale section structured to extend into the second end 128 of the hubassembly 120 to effectuate proper closure. Similarly, the second capsection 168 is preferably structured to be matingly coupled to thesecond inlet port 162 of the ventilator coupling 160, upon the hubassembly 120 and the ventilator coupling 160 being separated from oneanother. Significantly, however, it is preferred that the sterileengagement face 169 of the second cap section 168 be a female sectionstructured to receive the second inlet port 162 of the ventilatorcoupling 160 therein. Of course, the male and female configurations canbe varied to correspond the necessary configurations of the hub assembly120 and ventilator coupling 160, so long as they are oppositeconfigurations. Specifically, in the preferred embodiment, the first andsecond cap sections 130 and 168 are each positionable between an openposition and a closed position. In their respective closed positions,the corresponding sterile engagement faces 132 and 169 of the first andsecond cap sections 130 and 168 are correspondingly coupled in sealingrelation at the second end 128 of the hub assembly 120 and at the secondinlet port 162 of the ventilator coupling 160. When in the openposition, however, due to the preferred opposing configurations of thesterile engagement faces 132 and 169, the sterile engagement faces 132and 169 are structured to be selectively and matingly coupled with oneanother. Such coupling functions to maintain sterility of the sterileengagement faces 132 and 169 when not being used to cover the respectiveopenings. Moreover, such interconnection generally stows the sterile capassembly. It is seen that in a preferred embodiment, the first capsection 130 is tethered by an elongate segment to the hub assembly 120,preferably at an annular ridge 129 defined on the hub assembly 120, andthe second cap section 168 is similarly tethered by an elongate segmentto the ventilator coupling 160 at preferably an annular ridge defined onthe ventilator coupling 160.

While this invention has been shown and described in what is consideredto be a practical and preferred embodiment, it is recognized thatdepartures may be made within the spirit and scope of this inventionwhich should, therefore, not be limited except as set forth in theclaims which follow and within the doctrine of equivalents. Furthermore,it is noted that the device of the present invention may also beutilized with similar medical tubes, such as a thoracostomy tube.

Now that the invention has been described,

What is claimed is:
 1. An Endotracheal Tube Cleaning Apparatus to beused with an endotracheal tube having a distal end, a proximal end, andan interior wall structure defining a lumen therethrough; saidendotracheal tube cleaning apparatus comprising: an elongate tubularmember, said elongate tubular member having a distal end structured toextend into the endotracheal tube, and a cleaning assembly comprising: amaterial bladder coupled to said elongate tubular member and structuredto be inflated to a diameter substantially equivalent to at leastapproximately a diameter of the interior wall surface of theendotracheal tube, an inflation channel coupled in fluid flowcommunication with said material bladder and structured to direct aninflation fluid into said material bladder, an exterior abrasive surfacedisposed at least partially on said material bladder and structured toaffirmatively engage the interior wall surface of the endotracheal tube,under an outward, inflated pressure of said material bladder, and applycleaning pressure to the interior wall surface of the endotracheal tubeupon axial reciprocating movement of the elongate tubular member withinthe endotracheal tube, said exterior cleaning surface includingmedication thereon and structured to administer said medication at leastpartially through the endotracheal tube, and said material bladderincluding an at least partially ribbed exterior surface, said partiallyribbed exterior surface including a plurality of closely spaced,transverse ribs structured to intersect a path of said reciprocatingmovement of the elongate tubular member within the endotracheal tube andthereby define said exterior cleaning surface.